A.P.L. Purple Book BLA 017055

BLA number
017055
Proprietary names
A.P.L.
Proper names
chorionic gonadotropin
Applicant
Ferring Pharmaceuticals Inc.
Center
CDER
First observed release
2020-05-01
Latest observed release
2026-06-01
Newest archive release
2026-06-01
FDA patent list
No patents listed in the captured FDA patent list; source updated 2025-06-11
Coverage
Present in newest release

Latest Known Product Presentations#

Product, Proprietary name, Proper name table
ProductProprietary nameProper nameLicense typeStrengthDosage formRoutePresentationMarketingLicensureApprovalPatent list provided
001A.P.L.chorionic gonadotropin351(a)5,000UNITSFor InjectionIntramuscularSingle-Dose VialDiscVoluntarily Revoked1974-12-13
002A.P.L.chorionic gonadotropin351(a)10,000UNITSFor InjectionIntramuscularSingle-Dose VialDiscVoluntarily Revoked1974-12-13
003A.P.L.chorionic gonadotropin351(a)20,000UNITSFor InjectionIntramuscularSingle-Dose VialDiscVoluntarily Revoked1974-12-13

Published Patent List#

No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.

Official Monthly Change Events#

Release, Event, Product table
ReleaseEventProductNameLicense typeStatusApplicant
2026-04-01U001A.P.L.351(a)DiscFerring Pharmaceuticals Inc.
2026-04-01U002A.P.L.351(a)DiscFerring Pharmaceuticals Inc.
2026-04-01U003A.P.L.351(a)DiscFerring Pharmaceuticals Inc.
2020-05-01R001A.P.L.351(a)DiscFerring Pharmaceuticals Inc.
2020-05-01R002A.P.L.351(a)DiscFerring Pharmaceuticals Inc.
2020-05-01R003A.P.L.351(a)DiscFerring Pharmaceuticals Inc.

Observed Product State History#

Release, Product, Name table
ReleaseProductNameLicense typeMarketingLicensureApproval
2026-04-01001A.P.L.351(a)DiscVoluntarily Revoked1974-12-13
2026-04-01002A.P.L.351(a)DiscVoluntarily Revoked1974-12-13
2026-04-01003A.P.L.351(a)DiscVoluntarily Revoked1974-12-13
2020-05-01001A.P.L.351(a)DiscLicensed1974-12-13
2020-05-01002A.P.L.351(a)DiscLicensed1974-12-13
2020-05-01003A.P.L.351(a)DiscLicensed1974-12-13